CareFusion Recalls AVEA Ventilator Due to an Electrical Issue Which May Cause an Unexpected Shutdown

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product:

Product Description

Product Numbers

AVEA Standard with Compressor ventilator-refurbished

R17312-xx (xx = 0-14)

AVEA Comprehensive ventilator

17310-xx (xx = 0 -14)

AVEA Standard ventilator

17311-xx (xx = 0 -14)

AVEA Standard with Compressor ventilator

17312-xx (x=0 -14)

AVEA Comprehensive ventilator-refurbished

R17310-xx (xx = 0-14)

AVEA Standard ventilator-refurbished

R17311-xx (xx = 0-14)

AVEA Standard with Compressor ventilator-refurbished

R17312-xx (xx= 0-14)

TCA Board

16542A

GDE- 1st Generation

16222-001-99

GDE

16650A

GDE-refurbished

R16650A

AVEA GDE/UIM upgrade kit

12283-PMN

Image of recalled CareFusion AVEA ventilator

Manufacturing Dates: November 13, 2015 to January 4, 2016

Distribution Dates: December 16, 2015 to February 15, 2016

Devices Recalled in the U.S. 501 units distributed nationwide

Device Use

The AVEA ventilator is intended for continuous breathing support for infants, children and adults. The ventilator is only used in hospitals and other health care facilities.

Reason for Recall

CareFusion is recalling the AVEA Ventilator because of a faulty fuse on the ventilators’ alarm board, which may cause the ventilator to unexpectedly shut down. If the ventilator shuts down, a patient may not receive necessary oxygen. The use of affected product may cause serious adverse health consequences, including death.

Who May be Affected

Health care providers using AVEA ventilators

All patient groups who may be using these ventilator systems for breathing support